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Thousands miss out on stopping smoking due to varenicline disruption

Thousands of people missed out on quitting smoking for good and improving their health due to the disruption in the supply of nicotine withdrawal drug varenicline.

Thousands of people will have missed out on quitting smoking and improving their health due to the disruption in the supply of nicotine withdrawal drug varenicline (Champix).

The supply of the drug, which works by reducing cravings for nicotine and easing withdrawal symptoms, was paused in July 2021 in the UK and Europe as a precaution after higher than expected levels of a potentially harmful substance were found in the tablets.

The new study by UCL researchers, published in the journal Addiction and funded by Cancer Research UK, looked at survey responses and NHS prescription data to track how use of the drug had declined in England, finding it had fallen from 3.9% of all quit attempts in the second half of 2021 to 0% of quit attempts by the end of 2022.

They estimated that over a year with no varenicline prescriptions, this would mean 85,800 people not taking the drug who might otherwise have done.

As a result of smokers moving to less effective smoking cessation aids or not using any medication or nicotine replacement at all to help them quit, an estimated 4,200 fewer would have stopped smoking for good in a year, the researchers found. They estimated this would lead to 1,890 more smoking deaths for each year varenicline was unavailable. These deaths would occur over coming decades, with lifelong smokers losing an average of over 10 years of life compared to non-smokers.

Lead author Dr Sarah Jackson, of the UCL Tobacco & Alcohol Research Group, said: “Varenicline is a gold-standard prescription treatment for smokers trying to quit. The disruption of its supply in the UK and Europe likely reduced the number of people successfully stopping smoking, which will lead to more preventable deaths. Our study gives a sense of the scale of this.

“Fortunately, another prescription drug called cytisine became available in the UK in January that is similarly effective to varenicline and could help fill the gap. Efforts to promote awareness of cytisine among smokers and prescribers may help to reduce smoking deaths over the long term.”

Varenicline was paused due to high levels of nitrosamines

The distribution of varenicline was paused by the manufacturer, Pfizer, because of a higher than acceptable level of (potentially carcinogenic) nitrosamines in the tablets.

Following action from UK and EU regulators, healthcare staff in the UK were advised to return batches of the drug to their supplier in October 2021. Generic versions of the drug are currently available in the US, Canada and Australia but not in the UK.

Nitrosamines, which are thought to increase cancer risk if levels of exposure are high, are also present in tobacco.

The researchers noted that, if the nitrosamines in the tablets were similarly carcinogenic to tobacco-specific nitrosamines, a standard 12-week course of Champix (varenicline) would give an equivalent dose to smoking 198 cigarettes (18 days of smoking at a typical consumption of 11 cigarettes day). This is a much lower level of risk than continuing to smoke in the long term.

Senior author Professor Lion Shahab, of the UCL Tobacco & Alcohol Research Group, said: “The withdrawal of varenicline has had substantial unintended consequences. Our study suggests it will lead to thousands more avoidable deaths from smoking in England alone.

“Industry and regulators acted with caution, leading to a life-saving smoking cessation medicine becoming unavailable. Perhaps they did not fully consider the effects this would have on the health of continuing smokers, who are exposed to a much higher level of risk than that likely caused by nitrosamine impurities in varenicline.

“It is imperative that non-nicotine based smoking cessation pharmacotherapies, such as varenicline, bupropion and – most recently – cytisine, are made widely available to smokers who do not wish to use nicotine-containing products, including NRT or e-cigarettes, to help them quit smoking.”

Steady reduction in number of cigarettes smoked per person has stalled

Another UCL and Cancer Research UK study also shows that the decade-long decline in the number of cigarettes a person who smokes has per day is at risk.

The study revealed the steady reduction seen up to 2019 has now stalled, and some people actually smoke more. Researchers have found that the average person who smokes dropped from smoking 14 cigarettes per day in January 2008 to 11 cigarettes per day in October 2019. But the number hasn’t budged since. And people who smoke daily are getting through an extra cigarette every day now compared to 2019. 

Across the population there are still 45.5 million cigarettes smoked every day in England, down from 77.1 million per day in 2011.  So, while we have made progress, this study shows that the fight against tobacco is far from over. 

The study also showed that the average person who smokes is having 35% more hand-rolled cigarettes (up from 4 to 6 per day), and 47% fewer manufactured cigarettes (down from 10 to 5 per day). This trend was seen between January 2008 to September 2023.    

Researchers speculated that this shift is likely down to affordability of cigarette types driven by greater tax increases on manufactured cigarettes and exacerbated by the cost-of-living crisis.  

Dr Sarah Jackson said: “Some groups across England still smoke more heavily than others. It’s vital that smoking cessation services are made easily and equally available across the UK, so that those who want to quit smoking are given all the support they need to do so.”   

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